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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004167
Receipt No. R000005001
Scientific Title Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Date of disclosure of the study information 2010/09/07
Last modified on 2013/03/21

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Basic information
Public title Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Acronym Aprepitant inhibits PONV
Scientific Title Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Scientific Title:Acronym Aprepitant inhibits PONV
Region
Japan

Condition
Condition Patients undergoing dento-oral surgery
Classification by specialty
Anesthesiology Operative medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of NK-1 receptor antagonist on PONV
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Consumption of postoperative anti-emetic agent
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aprepitant 125 mg was preoperatively administered in 20 patients undergoing oro-dental-surgeries and postoperative neusea and vomiting is evaluated.
Interventions/Control_2 Metoclopramide 10 mg was administered just before completion fo surgery in 20 patients undergoing oro-dental-surgeries and postoperative neusea a vomiting is evaluated. Preoperative administration of metoclopramide
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria Patients for surgical correction of bite
Key exclusion criteria Patients with pregnancy, having vomiting with 24 h before surgery in any etiology, allergy to any medications to be used prtioperatively, hepatic and renal disfunction.
Patients taking medications known to induce or inhibit cytochrome P-450 3A4.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Masaki
Organization Tohoku University Graduate School of Dentistry
Division name Division of Dento-oral Anesthesiology
Zip code
Address 4-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-8401
Email

Public contact
Name of contact person
1st name
Middle name
Last name Syomu
Organization Tohoku University Graduate School of Dentistry
Division name Syomu
Zip code
Address
TEL
Homepage URL
Email den-syomu@bereau.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 07 Day
Last modified on
2013 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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